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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00415181
Other study ID # AKF-319pro
Secondary ID
Status Completed
Phase N/A
First received December 21, 2006
Last updated January 12, 2015
Start date September 2006
Est. completion date March 2013

Study information

Verified date December 2006
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

This study will try to determine whether or not certain genes are responsible for the huge variation in toxicity and effect observed between patients treated with paclitaxel (chemotherapeutic drug). Specifically we will study this in patients with ovarian cancer who receive paclitaxel/carboplatin chemotherapy after primary surgery.


Description:

Paclitaxel is an antineoplastic drug used in the treatment of ovarian cancer. The effect and toxicity is unpredictable in the individual patient. Paclitaxel is removed (eliminated) from the organism by oxidation. CYP2C8 is the enzyme mainly responsible. P-glycoprotein (Pgp) is an efflux transport protein natural to the human organism. Pgp is responsible for excretion of drugs via the bile and the kidneys and is thought to play a role in chemotherapy resistance. Paclitaxel is substrate for Pgp. Single nucleotide polymorphisms are possible causes for variation in both CYP2C8 and Pgp expression/function. We will study a possible role of these genetic variations as predictors of paclitaxel toxicity and effect and the possible implications for individual dosing in the future.

We want to determine the metabolic capacity of approximately 100 ovarian cancer patients and comparing this with genotypes, acute toxicity(eg. bone marrow suppression and neuropathy) and response to treatment(ie. CA125 response, progression free survival and overall survival). The metabolic capacity is estimated using a "sparse sampling" approach applying advanced computerized pharmacokinetic/dynamic modelling as opposed to traditional "frequent sampling" pharmacokinetic studies which burden the individual patient more.

Patients are recruited in collaboration with Oncological departments throughout Scandinavia.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date March 2013
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnose and histology of invasive epithelial ovarian/tuba or peritoneal cancer

- FIGO stage IIb-IV any grade or FIGO Ia-IIa only grade 3 or clear cell carcinoma (any stage and grade)

- Natural candidate for paclitaxel 175mg/m2 + Carboplatin (AUC=5-6)

- Baseline CA125=70 AND/OR evaluable disease after RECIST (incl ultrasound)

- 18 years or older

- Caucasian (ie.parents and grandparents are Caucasian)

- Performance status 2 or lower (after WHO/ECOG)

Exclusion Criteria:

- Prior malignant disease apart from cervical carcinoma in situ and basal cell carcinoma of the skin

- Prior chemo / radiotherapy

- Ongoing or imminent other chemotherapies

- Pregnant or lactating

- Fertile woman of childbearing potential not willing to use adequate contraception

- Neurological symptoms (any kind) worse than CTCAE grade 1

- Active infection or other serious disease that could impair on treatment and/or follow-up

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Department of oncology, Herlev Hospital Herlev
Denmark Department of Oncology, Odense University Hospital Odense
Denmark Department of Oncology, Vejle Hospital Vejle
Sweden Department of Oncology, University Hospital of Lund Lund

Sponsors (3)

Lead Sponsor Collaborator
University of Southern Denmark Danish Clinical Intervention Research Academy, Ministry of the Interior and Health, Denmark

Countries where clinical trial is conducted

Denmark,  Sweden, 

References & Publications (1)

Bergmann TK, Brasch-Andersen C, Gréen H, Mirza M, Pedersen RS, Nielsen F, Skougaard K, Wihl J, Keldsen N, Damkier P, Friberg LE, Peterson C, Vach W, Karlsson MO, Brosen K. Impact of CYP2C8*3 on paclitaxel clearance: a population pharmacokinetic and pharma — View Citation

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